The CTSA Mentored Career Development Program: Supporting the Careers of Child Health Investigators

Training translational scientists is a priority of the Clinical and Translational Science Award (CTSA) consortium. Objectives: 1) Describe the landscape of CTSA Mentored Research Career Development Awards (CDA) and 2) evaluate participation and outcomes of child health investigators in these programs. Design: Survey of the CTSA Child Health Oversight Committee (CC‐CHOC) and review of nonresponders'' CTSA Websites. Results: Thirty‐two of 53 CC‐CHOC members (60%) responded and all nonresponder Websites were reviewed. Institutions supported 1,166 CDA positions from 2006 to 2011, with 134 awarded to child health investigators (11.5%). Respondents reported a mean of 29.8 KL2 positions (95% CI 17.5–42.2) during their award period, with a mean of 2.8 (95% CI 1.8–3.8) awarded to child health investigators. The proportion of child health awardees varied from 0% to 50% across institutions. We identified 45 subsequent National Institutes of Health (NIH) awards to the 134 child health investigators (34%). Conclusions: The CTSA program contributes substantially to training the next generation of translational investigators. One‐third of child health investigators obtained subsequent NIH awards in the short follow‐up period demonstrating success of the CTSA CDA programs. Child health investigators are represented variably across the consortium. Pediatric institutions can partner with the CTSA program to further support training child health investigators.     

Models of Interinstitutional Partnerships between Research Intensive Universities and Minority Serving Institutions (MSI) across the Clinical Translational Science Award (CTSA) Consortium

Health disparities are an immense challenge to American society. Clinical and Translational Science Awards (CTSAs) housed within the National Center for Advancing Translational Science (NCATS) are designed to accelerate the translation of experimental findings into clinically meaningful practices and bring new therapies to the doorsteps of all patients. Research Centers at Minority Institutions (RCMI) program at the National Institute on Minority Health and Health Disparities (NIMHD) are designed to build capacity for biomedical research and training at minority serving institutions. The CTSA created a mechanism fostering formal collaborations between research intensive universities and minority serving institutions (MSI) supported by the RCMI program. These consortium‐level collaborations activate unique translational research approaches to reduce health disparities with credence to each academic institutions history and unique characteristics. Five formal partnerships between research intensive universities and MSI have formed as a result of the CTSA and RCMI programs. These partnerships present a multifocal approach; shifting cultural change and consciousness toward addressing health disparities, and training the next generation of minority scientists. This collaborative model is based on the respective strengths and contributions of the partnering institutions, allowing bidirectional interchange and leveraging NIH and institutional investments providing measurable benchmarks toward the elimination of health disparities.     

Nurse Engagement and Contributions to the Clinical and Translational Science Awards Initiative

CTSAs are mandated to follow a multidisciplinary model. Requests for applications direct responsive applications to “integrate clinical and translational science across multiple departments, schools,” listing disciplines in addition to medicine such as engineering, nursing, and public health. This inventory of nurse engagement in CTSAs describes the extent of nursing''s CTSA engagement from the perspective of participating nurse scientists within individual CTSAs, including institutional/national contributions and best practices that foster a multidisciplinary model. Of the 50 CTSAs affiliated with a nursing school, 44 responded (88% response rate). Of the ten CTSAs not affiliated with a nursing school, four responded (40% response rate). Overall funding success rates of nurse applicants are: TL1 fellowships 81%, KL2 fellowships 54%, and nurse‐led pilots 58%. At most CTSAs nursing is contributing to the accomplishment of the CTSA mandate. The strongest categories of contribution are community engagement, implementation science, and training. Best practices to enhance multidisciplinary collaboration are: (1) inclusion of multiple disciplines on key committees who meet regularly to guide individual core and overall CTSA strategic planning and implementation; (2) required multidisciplinary co‐mentors (ideally from different schools within the CTSA) on training grants and as co‐investigators on pilot projects; and (3) documentation of multidisciplinary activity in annual reports.     

Understanding the Supports of and Challenges to Community Engagement in the CTSAs

Background

The Clinical and Translational Science Award (CTSA) program has raised the profile and the available funding for engagement in biomedical research. Such increased funding and attention may address known barriers to engagement. However, little work has been done to describe experiences across multiple CTSAs, especially how the CTSA structure supports or challenges engagement.

Objective

We sought to understand the supports and challenges experienced by multiple CTSAs as they pursued community engagement. This knowledge may help guide future efforts to support and enhance community engagement in biomedical research.

Methods

We conducted semi‐structured, in‐depth interviews with CTSA community engagement core leaders and staff from the 2006 cohort of CTSAs (n = 12).

Results

A total of 17 interviews with respondents from nine institutions identified three support themes, including: funding, existing relationships with communities, and leadership and a partnership approach at the institution. Six challenge themes arose: need for capacity development, lack of positive relationships with communities, lack of leadership, funding constraints, time and staff constraints, and unsustainable models.

Conclusion

The CTSAs have brought much‐needed attention to community engagement in research, but more can be done to adequately support engagement. Challenges remain that need to be addressed to achieve the potential benefits of engagement.     

Survey of Community Engagement in NIH‐Funded Research

Community engagement is an innovative and required component for Clinical and Translational Science Awards (CTSAs) funded by the National Institutes of Health (NIH). However, the extent of community engagement in NIH‐funded research has not been previously examined. This study assessed baseline prevalence of community engagement activities among NIH‐funded studies at a large Midwestern university with a CTSA. An online survey was e‐mailed to principal investigators of recent NIH‐funded studies (N = 480). Investigators were asked to identify what types of community engagement activities had occurred for each study. Responses were received for 40.4% (194/480) of studies. Overall, 42.6% reported any community engagement activities. More collaborative types of engagement (e.g., community advisory board) were less common than activities requiring less engagement (e.g., sharing study results with community members). Studies with more collaborative community engagement were less likely to be described as basic or preclinical research compared to all other studies. Given NIH''s inclusive call for community engagement in research, relatively few NIH‐funded studies reported community engagement activities, although this study used a broad definition of community and a wide range of types of engagement. These findings may be used to inform the goals of CTSA community engagement programs. Clin Trans Sci 2010; Volume *: 1–4     

CTSA-IP: a solution to identifying and aggregating intellectual property across the NIH Clinical Translational Science Award (CTSA) consortium of biomedical research institutes

One of the objectives of the Consortium of Institutions with Clinical and Translational Science Awards (CTSAs) is to enhance technology transfer among the CTSAs and with public and private sector partners. Clinical and Translational Sciences Award Intellectual Property (CTSA-IP; http://www.CTSAIP.org) is a web-based, open access IP search tool that aggregates and promotes technologies from member institutions of the National Institutes of Health's (NIH) CTSAs consortium. Its ultimate aim is to stimulate collaborative research activity by encouraging the formation of public-private partnerships with CTSA institutions and the NIH. First launched in 2009, CTSA-IP has grown rapidly and met its first objectives of developing wide member institution participation and site usage. This communication will discuss the strategy employed in the initiative of aggregating IP across institutional boundaries, the promise that lies therein, as well as the challenges encountered and lessons learned in promoting CTSA-wide engagement.     

Developing Common Metrics for the Clinical and Translational Science Awards (CTSAs): Lessons Learned

The National Institutes of Health (NIH) Roadmap for Medical Research initiative, funded by the NIH Common Fund and offered through the Clinical and Translational Science Award (CTSA) program, developed more than 60 unique models for achieving the NIH goal of accelerating discoveries toward better public health. The variety of these models enabled participating academic centers to experiment with different approaches to fit their research environment. A central challenge related to the diversity of approaches is the ability to determine the success and contribution of each model. This paper describes the effort by the Evaluation Key Function Committee to develop and test a methodology for identifying a set of common metrics to assess the efficiency of clinical research processes and for pilot testing these processes for collecting and analyzing metrics. The project involved more than one‐fourth of all CTSAs and resulted in useful information regarding the challenges in developing common metrics, the complexity and costs of acquiring data for the metrics, and limitations on the utility of the metrics in assessing clinical research performance. The results of this process led to the identification of lessons learned and recommendations for development and use of common metrics to evaluate the CTSA effort.     

Community Engagement Strategies in the Original and Renewal Applications for CTSA Grant Funding

Purpose

The Clinical and Translational Science Award (CTSA) program has highlighted community engagement in research by requiring institutions to develop bidirectional relationships with communities to obtain funding. Little is known about how institutions have operationalized that requirement. This study aimed to describe the strategies proposed by the first institutions to receive CTSA funding and to undergo the CTSA renewal process.

Methods

The authors conducted a qualitative document analysis of the community engagement section of 12 original and 10 renewal grant applications of the 12 institutions awarded CTSA funding in 2006 and renewed in 2010.

Results

Institutions employed ‐ and research engagement strategies. Capacity‐building strategies included education, pilot grants, connecting potential partners, and community research centers. Research engagement strategies ranged from those that allowed for very little input from communities, such as announcements, to those that allowed for a high amount of input from communities, such as community‐researcher teams.

Conclusion

CTSA funding has supported capacity‐building for institutions and communities to partner. Engagement strategies employed by the institutions are largely known from prior community‐engaged research. Based on the grants from these institutions, the CTSA funding has largely enabled institutions to develop capacity to engage.     

Evaluating Various Areas of Process Improvement in an Effort to Improve Clinical Research: Discussions from the 2012 Clinical Translational Science Award (CTSA) Clinical Research Management Workshop

Emphasis has been placed on assessing the efficiency of clinical and translational research as part of the National Institutes of Health (NIH) goal to “improve human health.” Improvements identified and implemented by individual organizations cannot address the research infrastructure needs of all clinical and translational research conducted. NIH''s National Center for Advancing Translational Sciences (NCATS) has brought together 61 Clinical and Translational Science Award (CTSA) sites creating a virtual national laboratory that reflects the diversity and breadth of academic medical centers to collectively improve clinical and translational science. The annual Clinical Research Management workshop is organized by the CTSA consortium with participation from CTSA awardees, NIH, and others with an interest in clinical research management. The primary objective of the workshop is to disseminate information that improves clinical research management although the specific objectives of each workshop evolve within the consortium. The fifth annual workshop entitled “Learning by doing; applying evidence‐based tools to re‐engineer clinical research management” took place in June 2012. The primary objective of the 2012 workshop was to utilize data to evaluate, modify, and improve clinical research management. This report provides a brief summary of the workshop proceedings and the major themes discussed among the participants.     

Enhancing Dissemination,Implementation, and Improvement Science in CTSAs through Regional Partnerships

Background and Importance

Challenges in healthcare policy and practice have stimulated interest in dissemination and implementation science. The Institute of Medicine Committee on the Clinical Translational Science Award (CTSA) program recommended expanding the CTSA program''s investment and activity in this domain. Guidance is needed to facilitate successful growth of DII science infrastructure, activity and impacts.

Objectives

Several CTSAs in Southern California collaborated to identify and respond to local challenges and opportunities to expand dissemination, implementation and improvement research by strengthening capacity and relationships between DII researchers and community, health system, and population health partners.

Main outcomes

Planning and outreach by the Southern California CTSAs increased awareness and interest in DII research and generated recommendations for growth. Recommendations include: increasing strong partnerships with healthcare and population health systems to guide policy research agendas and collaborative DII science; promoting multi‐sector partnerships that involve researchers and delivery systems throughout DII processes; bringing together multiple disciplines; and addressing national and international barriers as well as opportunities in DII science.

Implications

CTSAs through regional collaboration can increase their contributions to improved community health via skill‐building, partnership development and enhanced outreach to local healthcare and public health agencies and delivery systems.     

Community Representatives’ Involvement in Clinical and Translational Science Awardee Activities

Objectives

To understand the formal roles of community representatives (CRs) in Clinical and Translational Science Awardee (CTSA) activities, to evaluate the extent of integration into the organizational and governance structures and to identify barriers to effective integration.

Methods

The inventory tool was distributed to each of the 60 CTSAs using a secure web application.

Results

Forty‐seven (78%) completed the inventory. The mean number of CRs per CTSA is 21.4 (SD: 14.8). Most CTSAs had community advisory boards (89%) and 94% included CRs in Community Engagement (CE) cores. Only 11% reported a CR being a member of the CTSA leadership team and 19% reported that CRs advise core programs beyond CE.CRs are compensated by 79% of CTSAs. Mean annual compensation is $753 (median: $400). Compensation directly correlated with the number of hours that CRs worked in CTSA activities (r = 0.64; P = 0.001).

Conclusions

This inventory allows CTSAs to better understand how CRs have engaged in activities and brings attention to the limited representation among cores and in leadership roles. CTSAs should, with substantive input from CRs, develop strategies to provide the resources and compensation necessary to better integrate the community in CTSA activities and fully realize the goals of the CTSA vision.     

Role for CTSAs in Leveraging a Distributed Research Infrastructure to Engage Diverse Stakeholders in Emergent Research Policy Development

This paper is a case study of our regional Clinical Translational Science Award''s (CTSA) development of a coordinated response to the advanced notice of proposed rulemaking on Human Subjects Research Protections during the fall of 2011. Our CTSA was well positioned to quickly activate and coordinate a response to this important and time sensitive issue because we had established infrastructure and resources both within our CTSA and through our partnering institutions, existing relationships with key individuals in the institutions, and credibility as a trusted source of information. Three town hall meetings were organized and a Website was created to collect online comments. Ultimately, comments were collected, prioritized, and organized into a single, coordinated response. This case study demonstrates the value of a distributed research infrastructure and the role CTSAs like our Institute of Translational Health Sciences can play to engage the regional research community about important developments in the research landscape and to respond to requests for feedback to policy makers. Clin Trans Sci 2013; Volume 6: 57–59     

Alignment of Emergency Medicine Research Efforts with Clinical and Translational Science Awards

The Clinical and Translational Science Awards (CTSA) represent a major new funding pathway for health science investigators seeking National Institutes of Health (NIH) funds. This new pathway provides institutional-level support for clinical and translational research and is not tied to one organ system or disease process, fitting well with emergency medicine (EM) research needs. These awards open unique opportunities for advancing EM research. The CTSA mechanism provides institutional support from the NIH to promote both clinical and translational science. Of the 60 expected awards, 38 sites are currently funded. EM investigators can benefit the institutions applying for these awards and simultaneously gain from involvement. Some opportunities for participation provided by the CTSA include research training programs, joining multidisciplinary research teams, seed grant funding, and use of the CTSA-developed research infrastructure. Involvement of EM can benefit institutions by enhancing acute care research collaboration both within and among institutions. Emergency medicine researchers at institutions either planning to submit a CTSA application or with funded CTSA grants are encouraged to become actively involved in CTSA-related research programs.     

A National Survey of Mentoring Programs for KL2 Scholars

There is limited information on how academic institutions support effective mentoring practices for new investigators. A national semistructured telephone interview was conducted to assess current “state of the art” mentoring practices for KL2 scholars among the 46 institutions participating in the Clinical Translational Science Awards (CTSA) Consortium. Mentoring practices examined included: mentor selection, articulating and aligning expectations, assessing the mentoring relationship, and mentor training. Telephone interviews were conducted in winter/fall 2009, with 100% of the CTSAs funded (n= 46) through 2009, participating in the survey. Primary findings include: five programs selected mentors for K scholars, 14 programs used mentor contracts to define expectations, 16 programs reported formal mentor evaluation, 10 offered financial incentives to mentors, and 13 offered formal mentoring training. The interviews found considerable variation in mentoring practices for training new investigators among the 46 CTSAs. There was also limited consensus on “what works” and what are the core elements of “effective mentoring practices. Empirical research is needed to help research leaders decide on where and how to place resources related to mentoring. Clin Trans Sci 2010; Volume 3: 299–304     

Evaluation Guidelines for the Clinical and Translational Science Awards (CTSAs)

The National Center for Advancing Translational Sciences (NCATS), a part of the National Institutes of Health, currently funds the Clinical and Translational Science Awards (CTSAs), a national consortium of 61 medical research institutions in 30 states and the District of Columbia. The program seeks to transform the way biomedical research is conducted, speed the translation of laboratory discoveries into treatments for patients, engage communities in clinical research efforts, and train a new generation of clinical and translational researchers. An endeavor as ambitious and complex as the CTSA program requires high‐quality evaluations in order to show that the program is well implemented, efficiently managed, and demonstrably effective. In this paper, the Evaluation Key Function Committee of the CTSA Consortium presents an overall framework for evaluating the CTSA program and offers policies to guide the evaluation work. The guidelines set forth are designed to serve as a tool for education within the CTSA community by illuminating key issues and practices that should be considered during evaluation planning, implementation, and utilization. Additionally, these guidelines can provide a basis for ongoing discussions about how the principles articulated in this paper can most effectively be translated into operational reality.     

Report on CTSA Consortium Use of the Community Engagement Consulting Service

Introduction

The CTSA Community Engagement Consultative Service (CECS) is a national partnership designed to improve community engaged research (CEnR) through expert consultation. This report assesses the feasibility of CECS and presents findings from 2008 to 2009.

Methodology

A coordinating center and five regional coordinating sites managed the service. CTSAs identified a primary previsit CE best practice for consultants to address and completed self‐assessments, postvisit evaluations, and action plans. Feasibility was assessed as the percent of CTSAs participating and completing evaluations. Frequencies were calculated for evaluation responses.

Results

Of the 38 CTSAs, 36 (95%) completed a self‐assessment. Of these 36 sites, 83%, 53%, and 44% completed a consultant visit, evaluation, and action plan, respectively, and 56% of the consultants completed an evaluation. The most common best practice identified previsit was improvement in CEnR (addressing outcomes that matter); however, relationship building with communities was most commonly addressed during consulting visits. Although 90% of the consultants were very confident sites could develop an action plan, only 35% were very confident in the CTSAs’ abilities to implement one.

Conclusions

Academic medical centers interested in collaborating with communities and translating research to improve health need to further develop their capacity for CE and CEnR within their institutions. Clin Trans Sci 2013; Volume 6: 34–39     

Assessing the Impact of the NIH CTSA Program on Institutionally Sponsored Clinical Trials

Objective

To assess the impact of the NIH CTSA program on patient enrollment in clinical trials sponsored/collaborated by CTSA consortium institutions.

Material and Methods

Using publicly available clinical trial data at ClinicalTrials.gov, we identify positive trend changes in the number of patients enrolled in clinical trials performed at CTSA consortium institutions over the years before and after their respective CTSA award dates. CTSA consortium institutions were matched with similar non‐CTSA institutions.

Results

As compared to matched non‐CTSA institutions CTSA consortium sites noted an increase in patient enrollment after the CTSA awards. In particular, we detected a change‐point, where a new enrollment trend emerged, 338 days after the CTSA award. No such trend was noted over the same period in the non‐CTSA institutions.

Conclusion

Our analysis provides evidence that the NIH CTSA funding program made a positive impact on patient enrollment.     

Faculty Perceptions of How Community‐Engaged Research Is Valued in Tenure,Promotion, and Retention Decisions

Purpose

We assessed the perceptions of community core faculty in academic medical center institutions that received Clinical and Translational Science Awards (CTSA) about how these institutions consider community‐engaged scholarship (CES) when tenure, promotion, and retention decisions are made.

Method

An assessment tool was adapted to create an 18‐item survey that was sent during November and December 2011 via the Internet to the 369 members of the community‐engagement core mailing list of the CTSA.

Results

Fifty‐nine responses were received which represented 37 of the possible 60 different funded institutions. The mean score was 48.14 (SD = 11.18); range of 23–74; and Cronbach''s alpha was .91 About half reported that support for CES and its inclusion in the academic decision process increased since the institution was awarded a CTSA. Open‐ended responses indicated some confusion with terminology although a definition of CES had been provided in the instrument instructions.

Conclusion

Respondents overall agreed there was moderate support for CES in tenure, promotion, and retention decisions which may have been influenced by the CTSA application requirements. This survey could be used to identify if there are differences in institutional and departments and measure changes over time.     

Social Network Analysis to Assess the Impact of the CTSA on Biomedical Research Grant Collaboration

Success of the Clinical Translational Science Award (CTSA) program implicitly demands team science efforts and well‐orchestrated collaboration across the translational silos (T1–T4). Networks have proven to be useful abstractions of research collaborations. Networks provide novel system‐level insights and exhibit marked changes in response to external interventions, making them potential evaluation tools that complement more traditional approaches. This study is part of our ongoing efforts to assess the impact of the CTSA on Biomedical Research Grant Collaboration (BRGC). Collaborative research grants are a complex undertaking and an outcome of sustained interaction among researchers. In this report, BRGC networks representing collaborations among CTSA‐affiliated investigators constructed from grants management system data at the University of Kentucky across a period of six years (2007–2012) corresponding to pre‐ and post‐CTSA are investigated. Overlapping community structure detection algorithms, in conjunction with surrogate testing, revealed the presence of intricate research communities rejecting random graphs as generative mechanisms. The deviation from randomness was especially pronounced post‐CTSA, reflecting an increasing trend in collaborations and team‐science efforts potentially as a result of CTSA. Intercommunity cross talk was especially pronounced post‐CTSA.     

Academic Medical Product Development: An Emerging Alliance of Technology Transfer Organizations and the CTSA

To bring the benefits of science more quickly to patient care, the NIH National Center Advancing Translational Sciences (NCATS) supports programs that enhance the development, testing, and implementation of new medical products and procedures. The NCATS clinical and translational science award (CTSA) program is central to that mission; creating an academic home for clinical and translational science and supporting those involved in the discovery and development of new health‐related inventions. The technology transfer Offices (TTO) of CTSA‐funded universities can be important partners in the development process; facilitating the transfer of medical research to the commercial sector for further development and ultimately, distribution to patients. The Aggregating Intellectual Property (IP) Working Group (AWG) of the CTSA public private partnerships key function committee (PPP‐KFC) developed a survey to explore how CTSA‐funded institutions currently interface with their respective TTOs to support medical product development. The results suggest a range of relationships across institutions; approximately half have formal collaborative programs, but only a few have well‐connected programs. Models of collaborations are described and provided as examples of successful CTSA/TTO partnerships that have increased the value of health‐related inventions as measured by follow‐on funding and industry involvement; either as a consulting partner or licensee.